Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-02 @ 7:46 AM
Study NCT ID:
NCT05867992
Status:
RECRUITING
Last Update Posted:
2024-09-05
First Post:
2023-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples from patients with acute severe traumatic brain injury.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-01', 'studyFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of differently expressed proteins in patients' serum detected by proteomic", 'timeFrame': 'First 12 hours in the emergency room', 'description': "Patients' serum will be collected in the emergency room. After collecting all samples, these samples will be detected through proteomic mass spectrometry. The results of proteomic will be further analyzed and compared with control group to filter potential protein biomarkers in serum of severe TBI patients in acute phase."}, {'measure': "Number of differently expressed metabolites in patients' serum detected by metabolomic", 'timeFrame': 'First 12 hours in the emergency room', 'description': "Patients' serum will be collected in the emergency room. After collecting all samples, these samples will be detected through metabolomic mass spectrometry. The results of metabolomic will be further analyzed and compared with control group to filter potential metabolite biomarkers in serum of severe TBI patients in acute phase."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Traumatic brain injury', 'Biomarker', 'Multiomic analysis', 'Diagnosis'], 'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': "The goal of this experimental observation study is to figure out differently expressed biomarkers in serum in traumatic brain injury patients, compared with bone fracture patients. The main questions it aims to answer are:\n\n1. Which proteins and metabolites are differently expressed in TBI patients' serum?\n2. Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? Participants will be treated by routine treatments, and their serum samples will be collected in the emergency room.", 'detailedDescription': "This experimental observation study is designed to find out some new characteristics in acute severe traumatic brain injury. To filter the stress response in blood, patients with traumatic fracture are chosen as the control group.\n\nBlood samples of patients who pass the eligibility criteria will be collected immediately in the emergency room. Then the samples will be preprocessed in the laboratory to get serums. These collected serums will be preserved in -80℃ until completing all sample collection. After completing collection, all samples will be sent to proteomic and metabolomic detection. The bioinformatic data will be analyzed to answer these main questions:\n\n1. Which proteins and metabolites are differently expressed in TBI patients' serum? (As a whole characteristic of acute severe TBI)\n2. Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? (Deeply digging the value of characteristic of acute severe TBI)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the case group are these with brain injury, caused by trauma and are severe (GCS 3-8) and in acute period (within 12 hours). Meanwhile, these patients should not have acute bone fracture or other orthopaedic diseases, to avoid any biological detecting bias to control group.\n\nPatients in the control group are these with bone fracture, caused by trauma and in acute period (within 12 hours). Also, these patients should not have acute brain injury or other neurological diseases to avoid the same bias in biological detection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With cerebral contusion in 24Hrs for case group, or with traumatic bone fracture in 24Hrs for control group.\n* The Glasglow Coma Scale ranges in 3-8 for case group.\n* Need to have routine laboratory examination of blood sample.\n* Patients or agents sign the informed consent.\n\nExclusion Criteria:\n\n* With bone fracture for case group, or with brain injury for control group.\n* Have Orthopaedic history for case group, or have Neurological history for control group.\n* Death in 24 hours.\n* Immunosuppressed state.\n* Severe multiple organ dysfunction.\n* With infection.\n* Pregnant.'}, 'identificationModule': {'nctId': 'NCT05867992', 'acronym': 'MASTER-TBI', 'briefTitle': 'Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Proteomic and Metabolomic Detection and Analysis of Serum from Patients with Acute Severe Traumatic Brain Injury: a Prospective, Multicentered Study', 'orgStudyIdInfo': {'id': 'LY2024-006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case group', 'description': 'This group enrolls patients with acute severe traumatic brain injury.', 'interventionNames': ['Other: Type of trauma']}, {'label': 'Control group', 'description': 'This group enrolls patients with acute traumatic bone fracture but without traumatic brain injury.', 'interventionNames': ['Other: Type of trauma']}], 'interventions': [{'name': 'Type of trauma', 'type': 'OTHER', 'description': 'Patients in case group have the severe traumatic brain injury, while patients in control group have the traumatic bone fracture without brain injury.', 'armGroupLabels': ['Case group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201114', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junfeng Feng, Ph.D.', 'role': 'CONTACT', 'email': 'fengjfmail@163.com', 'phone': '+8613611860825'}, {'name': 'Junfeng Feng, Ph.D.', 'role': 'CONTACT'}, {'name': 'Jiyuan Hui, Ph.D.', 'role': 'CONTACT'}, {'name': 'Ru Gong, Ph.D.', 'role': 'CONTACT'}, {'name': 'Weiji Weng, Ph.D.', 'role': 'CONTACT'}, {'name': 'Weiyuan Xiao, Ph.D.', 'role': 'CONTACT'}], 'facility': 'Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhenghui He, M.D.', 'role': 'CONTACT', 'email': 'hezhenghui8@qq.com', 'phone': '+8613585916217'}, {'name': 'Weiji Weng, Ph.D.', 'role': 'CONTACT', 'email': 'zigzagweng@163.com', 'phone': '+8613916673435'}], 'overallOfficials': [{'name': 'Junfeng Feng, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Brain Injury Center', 'investigatorFullName': 'Junfeng Feng', 'investigatorAffiliation': 'RenJi Hospital'}}}}